TORONTO, March 30, 2026 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announced that it has entered into a binding Letter of Intent (LOI) with Allucent, a global contract research organization with extensive experience supporting central nervous system clinical trials, to support the planned Phase 2 clinical trial of Lucid ...

Strategic Partnership with Global Clinical Research Organization (CRO) Signifies Advancement in Clinical Development of Lucid-21-302 (Lucid-MS), a Novel First-in-Class Treatment Inhibiting DemyelinationTORONTO, March 30, 2026 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announced that it has entered into a binding Letter ...

BL1107 FIRST GLAUCOMA THERAPY TO IMPROVE VISUAL FUNCTION THROUGH NEUROPROTECTION ELIOS FIRST CLINICIALLY VALIDATED IMPLANT-FREE MIGS EXCIMER LASER Disclaimers Forward-Looking Statements This presentation contains forward-looking information and statements, within the meaning of applicable securities laws (collectively, "forward-looking statements"), including, but not limited to, statements our focus on pipeline innovation, the success of our pipeline products and R&D programs, the existence of potential ga ...

Summary of Immunic Conference Call Company Overview - **Company**: Immunic - **Key Product**: Vidofludimus calcium, a drug in development for treating multiple sclerosis (MS) Industry Context - **Market**: Multiple Sclerosis (MS) treatment landscape, which includes various therapies with differing safety and efficacy profiles Key Points 2026 Outlook - 2026 is expected to be transformative for Immunic with the phase 3 readout of ENSURE-1 and ENSURE-2 studies planned for the end of the year [1] - NDA submission for vidofludimus calcium is planned for the following year [1] Drug Mechanism and Safety Profile - Vidofludimus calcium is designed as a safer and more selective DHODH inhibitor compared to Aubagio, avoiding off-target activities that lead to side effects [3][4] - The drug activates the nuclear receptor Nurr1, providing neuroprotective effects and solid anti-inflammatory activity [3][7] - Safety data indicates that vidofludimus calcium has a favorable liver toxicity profile compared to teriflunomide, with liver enzyme elevations comparable to placebo [10] - The elimination half-life of vidofludimus calcium is approximately 30 hours, allowing for quicker clearance compared to teriflunomide, which has a half-life of 10-19 days [11] Clinical Data and Efficacy - In the EMPhASIS study, vidofludimus calcium showed a 57% lower rate of confirmed disability progression compared to the control group [13] - The CALLIPER study indicated a 31% reduction in confirmed disability worsening in primary progressive MS (PPMS) patients [16] - The primary endpoint for upcoming studies will be time to first relapse, with secondary endpoints including confirmed disability progression and improvement [20] Market Positioning - Vidofludimus calcium aims to capture the oral medication segment, which constitutes 35%-40% of all prescriptions in the U.S. for MS [26] - The drug is positioned to address unmet needs in patients transitioning from CD20 therapies, which have serious infection risks [30] - The company believes that vidofludimus calcium will offer a best-in-class benefit-risk profile, particularly for patients preferring oral administration [27] Future Plans - A confirmatory study for PPMS is expected to start in the second half of the year, with an estimated duration of 3.5-4 years for enrollment and data readout [38] - The company anticipates significant market potential, estimating a multi-billion dollar upside for the PPMS indication [41] Conclusion - Immunic is optimistic about the upcoming data and believes that vidofludimus calcium could provide a new treatment option for individuals living with MS, addressing both relapsing and progressive forms of the disease [40][41]

Summary of Immunic's Conference Call Company Overview - **Company**: Immunic - **Product**: Vidofludimus calcium - **Focus**: Treatment for multiple sclerosis (MS) Key Points Unique Mechanism of Action - Vidofludimus calcium activates Nurr1, a nuclear receptor involved in neuroprotection, which differentiates it from other MS treatments [4][7] - It also acts as a DHODH inhibitor, providing an established anti-inflammatory mechanism [4][7] Clinical Data and Efficacy - The EMPHASIS study showed: - 76% reduction in cumulative active lesions - 78% reduction in gadolinium-enhancing lesions [20] - A numerical reduction of disability progression (CDW) by over 50% in the phase 2 study [14] - Safety and tolerability were comparable to placebo, indicating a favorable profile [21] Comparison with Other Treatments - Current oral therapies show efficacy rates of 30%-50% for glatiramer acetate and Aubagio, while anti-CD20 therapies show 80%-90% [22][24] - Vidofludimus calcium aims to provide a better benefit-risk profile, especially for patients who cannot tolerate existing therapies [43] Market Opportunity - The oral therapy market represents 35%-40% of total prescriptions for MS [77] - An estimated 5%-10% of patients on anti-CD20 therapies may need to switch due to serious infections, representing a potential $1 billion market in the U.S. alone [80][81] - The average cost of branded oral therapies is projected to be around $120,000 WAC at launch [85] Phase 3 Studies - The ENSURE studies for relapsing MS are fully enrolled, with primary endpoints focused on time to first relapse and secondary endpoints including MRI biomarkers and disability progression [57][58] - Expected readout for the studies is at the end of the year [62] Progressive MS Treatment - Immunic is also targeting primary progressive MS (PPMS) with a phase 2 study showing a 31% reduction in disability progression [112][113] - The potential market for PPMS is significant, with Roche's Ocrevus generating over $3 billion in sales from this segment [151] Safety Profile - Vidofludimus calcium has shown a clean safety profile with low rates of adverse events compared to existing therapies [46][48] - No significant liver enzyme changes were observed, differentiating it from other DHODH inhibitors [54] Future Outlook - Immunic plans to initiate pivotal studies for PPMS, with expectations of replicating positive data from previous studies [155] - The company believes it has a differentiated asset that could capture significant market share in both relapsing and progressive MS [161] Conclusion - Immunic is positioned to address unmet needs in the MS market with vidofludimus calcium, focusing on both relapsing and progressive forms of the disease, while emphasizing safety and tolerability as key differentiators [161]

Company Overview - Oculis is a global biopharma company listed on NASDAQ, focusing on ophthalmology and neuro-ophthalmology with late-stage registrational candidates [2] - The company has three candidates in Phase III trials and two main franchises [2] Product Pipeline - The first franchise includes OCS-01, which is the first noninvasive self-administered eye drop for diabetic macular edema (DME), with a readout planned for Q2 of this year [3] - The second candidate in this franchise is Licaminlimab, aimed at treating dry eye disease, with a readout expected in Q4 2026 [3] Neuro-Ophthalmology Franchise - The second franchise focuses on neuro-ophthalmology, featuring privosegtor, which is the first product to demonstrate effectiveness in neuroprotection [4] - Privosegtor has shown consistent results in preserving neurons across all endpoints, including functional, anatomical, and biological measures [4]

Summary of Oculis Conference Call Company Overview - **Company**: Oculis - **Industry**: Biopharmaceuticals, specifically in ophthalmology and neuro-ophthalmology - **Stock Exchange**: Nasdaq-listed - **Financial Position**: Strong balance sheet with no debt, cash runway until 2029 excluding a facility loan of CHF 100 million ($125 million) [2][3] Key Products and Pipeline Ocular Franchise - **OCS-01**: - First non-invasive self-administered eye drop for diabetic macular edema (DME) - Phase 3 readout planned for Q2 2023 - Targets a market of 1.8 million diagnosed patients in the US, with only half currently treated [2][5][6] - Demonstrated a 7.6 letters gain in best-corrected visual acuity (BCVA) at week 12 in trials, with 27% of patients gaining more than 15 letters [10] - Expected submission for approval in Q4 2023, with potential approval in 2027 [12] - **Licaminlimab**: - First precision medicine in ophthalmology for dry eye disease - Utilizes a biomarker to identify high responders, allowing for smaller and more efficient Phase 3 trials [12][13] - Expected top-line results in Q4 2026 [41] Neuro-Ophthalmology Franchise - **Privosegtor**: - First product in neuroprotection, targeting optic neuritis and NAION - Received Breakthrough Therapy Designation - Demonstrated preservation of retinal and ganglion cells in trials, with significant functional improvements [16][21] - Market potential of $7 billion for optic neuritis and NAION, with no current solutions available [18] - Phase 3 trials (Pioneer 1 and Pioneer 2) expected to start in 2026, with readouts planned for 2027 [23][35] Market Opportunity - **DME Market**: - Significant unmet medical need with a large patient pool, as DME is the leading cause of blindness in the working-age population in the US [34] - OCS-01 aims to address both early intervention and patients not responding to current treatments [7][9] - **Neuro-Ophthalmology Market**: - High potential due to the lack of existing treatments for conditions like optic neuritis and NAION, which are closely linked to multiple sclerosis (MS) [19][20] - Plans to expand treatment to all types of MS relapses, significantly increasing the addressable market [40] Strategic Focus - **Commercial Strategy**: - Focus on the US market for launch, with potential partnerships for ex-US markets [26] - Emphasis on innovative and differentiated product profiles to ensure successful commercial launches [26] - **Execution and Risk Management**: - Acknowledgment of execution risk as a primary concern, with a commitment to high-quality trial execution [31][32] - Confidence in the biological efficacy of products based on consistent preclinical and clinical data [39] Manufacturing and Partnerships - **Manufacturing Strategy**: - Oculis does not have in-house manufacturing capabilities; instead, it partners with established global manufacturers to maintain flexibility and quality [44] Conclusion - Oculis is positioned to make significant advancements in the ophthalmology and neuro-ophthalmology sectors with its innovative product pipeline, addressing critical unmet medical needs and leveraging a strong financial position for future growth [25]

Visionary Innovation Riad Sherif, M.D. Chief Executive Officer J.P. Morgan Healthcare Conference January 14, 2026 Safe Harbor Statements Cautionary note on forward-looking statements These slides and the accompanying oral presentation contain forward-looking statements and information. The use of words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identi ...

Core Insights - Immunic, Inc. has completed enrollment for both Phase 3 ENSURE trials of vidofludimus calcium in relapsing multiple sclerosis (RMS), with top-line data expected by the end of 2026 [1][2][6] - Phase 2 CALLIPER data demonstrated that vidofludimus calcium significantly reduced 24-week confirmed disability worsening (CDW) and increased 24-week confirmed disability improvement (CDI) across progressive multiple sclerosis (PMS) and its subtypes, highlighting the drug's neuroprotective mechanism [1][2][6] - Long-term open-label data from the Phase 2 EMPhASIS trial showed low rates of confirmed disability worsening events in patients with relapsing-remitting multiple sclerosis (RRMS), indicating favorable long-term safety and tolerability [1][2][6] - The company received a U.S. patent for dose strengths of vidofludimus calcium in PMS, extending intellectual property protection until 2041 [1][2][6] Vidofludimus Calcium Highlights - Enrollment completed for ENSURE-1 with 1,121 patients and ENSURE-2 with 1,100 patients across over 100 sites in 15 countries [6] - Positive results from the CALLIPER trial showed statistically significant improvements in 24wCDI and reductions in thalamic atrophy and new or enlarging T2 lesion volume compared to placebo [6] - At week 144 of the EMPhASIS trial, 92.3% of patients remained free of 12wCDW and 92.7% free of 24wCDW, with no new safety signals reported [6] IMU-856 Highlights - IMU-856 demonstrated a dose-dependent increase in endogenous glucagon-like peptide-1 (GLP-1) levels and a reduction in body weight gain in preclinical testing, indicating potential for weight management [6] - The company is preparing for further clinical testing of IMU-856, contingent on financing, licensing, or partnering [6] Corporate Developments - Immunic closed a $5.1 million registered direct offering and an oversubscribed $65 million underwritten public offering [6] - The company will host one-on-one meetings at the 44th Annual J.P. Morgan Healthcare Conference in January 2026 [5]

Core Insights - Oculis Holding AG's neuroprotective candidate Privosegtor has received Breakthrough Therapy Designation from the FDA for the treatment of optic neuritis, highlighting its potential as a first-of-its-kind therapy in this area [1][7]. Company Overview - Oculis is a global biopharmaceutical company focused on innovations in neuro-ophthalmology and ophthalmology, with a late-stage clinical pipeline that includes Privosegtor, OCS-01, and Licaminlimab [15]. Product Details - Privosegtor is a novel peptoid small molecule designed to penetrate both the blood-brain and retinal barriers, potentially addressing significant unmet medical needs in optic neuropathies, with a market opportunity estimated at $7 billion in the U.S. alone [2][5]. - The drug has shown substantial improvements in visual function, with an average gain of 18 letters in Low Contrast Visual Acuity (LCVA) compared to placebo in the Phase 2 ACUITY trial [4][7]. Clinical Trial Insights - The ACUITY trial demonstrated that Privosegtor not only improved visual function but also preserved anatomical structures of the retina and optic nerve, indicating its neuroprotective potential [3][4]. - The trial involved 36 patients with acute optic neuritis, showing that those treated with Privosegtor alongside IV methylprednisolone experienced significant visual improvements [12]. Regulatory and Market Implications - Following a successful meeting with the FDA, Oculis initiated the PIONEER program, which includes three pivotal trials aimed at supporting registration plans for Privosegtor in optic neuritis and non-arteritic anterior ischemic optic neuropathy (NAION) [5][6]. - The unmet medical needs in these conditions are significant, as there are currently no approved neuroprotective therapies available [10][11].